Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here)

On-line Audio Seminar 214

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

Recorded (Available with all reference material as mp3 download or on CD)

with Dennis Cantellops, US FDA, as Guest Speaker

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.

Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations. The question is how to do this.

Questions related to Excel® are:

• What exactly is required by the regulations?
• What are the limitations of 'out of the box Excel'?
• What does GAMP®5 suggest for Spreadsheets?
• Specific recommendations from the New Annex 11
• How to overcome Excel® limitations for Part 11 and other regulations?
• What should we validate?
• Should we test standard Excel® functions?
• Should we validate ad 'hoc' or 'one time use' Excel® spreadsheets?
• We use Excel templates as calculator, do we need to keep electronic records?
• What and how much should we document?
• When can we delete e-records and when should we keep them?
• How does the FDA comply with their own regulations?
• How to apply risk based validation to Excel spreadsheets?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. Dennis Cantellops from the US FDA will answer questions and share his experience. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
• Recommendations from the new GAMP®5 and Annex 11
• How to design spreadsheets for compliance.
• How to ensure and validate spreadsheet integrity.
• When, what and how much to test?
• Validation of standard/native Excel functions?
• How to apply risk based validation to spreadsheet applications
• Validation of 'ad hoc' spreadsheet applications.
• How to document planning, specifications, installation, testing and changes
• Examples from manufacturing, laboratories and offices

And learn from FDA's Dennis Cantellops specifically:

• Main problems found during FDA inspections
• How FDA uses spreadsheets in its own regulated organizations
• What FDA inspectors are looking for during inspections
• What to test and what not to test
• FDA's approaches for single user and multi user spreadsheets
• FDA's approach toward 3rd party add-on software for Excel compliance
• FDA's expectation for documentation
• Review requirements for spreadsheets

And for easy and instant implementation:
download 10+ documents from special seminar website

•  Two FDA Laboratory Information Bulletins (not available from FDA's public website).: -Spreadsheet design and validation for the multi-user and single user applications.
• SOPs:
  - Validation of spreadsheet applications
  - Development and use of spreadsheets in regulated environments
• Gap analysis/checklist for Macros and Spreadsheet applications
• Examples
  - Spreadsheet validation project schedule
  - Requirement specification
  - Installation documentation
  - Traceability matrix
  - Protocols for functional testing
  - Summary test sheet
  - Validation report
• Article (Published in Biopharm): Using Macros and Spreadsheets in Regulated Environment
• Software and validation package: File integrity check with MD5 Hash Calculations
• FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Excel
• And more....

Who should attend?

• All developers and users of spreadsheet applications
• Validation specialists
• QA managers and personnel
• Production and lab managers
• Regulatory affairs
• Training department
• Documentation department
• Consultants

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

About Guest Speaker Dennis Cantellops, US FDA, and Presenter Dr. Ludwig Huber

Dennis Cantellops (right) with Ludwig Huber (left). Dennis is quality manager at the FDA Laboratory in San Juan, Puerto Rico, He is the author of FDA's SOPs and Laboratory Information Bulletins about using Excel spreadsheets. He is also FDA field investigator with national but also international experience

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.